Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

PHASE3UnknownINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

October 13, 2017

Primary Completion Date

December 31, 2020

Study Completion Date

April 30, 2021

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

GB242

GB242: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10\~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses

BIOLOGICAL

Infliximab

Infliximab: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10\~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses

Trial Locations (1)

100044

RECRUITING

Peking University People Hospital, Beijing

Sponsors
All Listed Sponsors
lead

Genor Biopharma Co., Ltd.

INDUSTRY